UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012809
Receipt number R000014941
Scientific Title Effects of optimizing circulatory dynamics on patients outcomes by using a less invasive monitoring device in high-risk surgeries:a pilot study
Date of disclosure of the study information 2014/01/15
Last modified on 2015/08/12 19:02:32

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Basic information

Public title

Effects of optimizing circulatory dynamics on patients outcomes by using a less invasive monitoring device in high-risk surgeries:a pilot study

Acronym

Circulatory dynamics optimizing study

Scientific Title

Effects of optimizing circulatory dynamics on patients outcomes by using a less invasive monitoring device in high-risk surgeries:a pilot study

Scientific Title:Acronym

Circulatory dynamics optimizing study

Region

Japan


Condition

Condition

Esophageal cancer
Pancreatic cancer
Thoracoabdominal aortic aneurysm

Classification by specialty

Hepato-biliary-pancreatic surgery Vascular surgery Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of intraoperative circulatory management using the parameters of a less invasive monitoring device (FloTrac/Vigileo system) on the patients short term outcomes and the reduction in intra-and postoperative medical care costs.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Postoperative length of hospital stay

Key secondary outcomes

Intra-and postoperative medical expenses


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Bolus administration of 200ml of colloid when stroke volume variation is 13% or less

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

95 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Patients undergoing surgery due to esophageal cancer, pancreatic cancer, thoracoabdominal aortic aneurysm
2. Patinets of weight >40kg
3. Patients for whom arterial catheter is clinically needed for intraoperative continuous monitoring of arterial pressure.
4. Patients twenty years or older of age when undergoing the operation

Key exclusion criteria

1.Patients under twenty years of age
2.Patients with cardiac arrhythmia
3.Patients of Body Mass Inedex >40
4.Patients undergoing emergency surgeries
5.Patients who have not signed the informed concent
6.Patients undergoing repeat intervention due to postoperative hemorrhage

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiyasu Suzuki

Organization

Tokai University School of Medicine

Division name

department of anesthesia

Zip code


Address

143 Shimokasuya, Isehara, Kanagawa, 259-1193

TEL

0463-93-1211

Email

suzuki3@is.icc.u-tokai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Ito

Organization

Tokai University School of Medicine

Division name

department of anesthesia

Zip code


Address

143 Shimokasuya, Isehara, Kanagawa, 259-1193

TEL

0463-93-1211

Homepage URL


Email

itokenji@is.icc.u-tokai.ac.jp


Sponsor or person

Institute

Tokai University School of Medicine department of anesthesia

Institute

Department

Personal name



Funding Source

Organization

Edwards Lifesciences Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東海大学医学部付属病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 03 Month 05 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 06 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 10 Day

Last modified on

2015 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014941


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name